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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - April 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for April 2024 (PDF).

This issue reminds clinicians of the risk of psychiatric and sexual side effects seen in association with finasteride and notes that these effects can persist after discontinuation of treatment. It is recommended that patients are asked if they have a history of depression or suicidal ideation before commencing treatment and are advised to seek medical advice should symptoms develop during treatment. A patient card will be introduced in all finasteride packs, which will highlight the risk of sexual side effects and psychiatric side effects reported with finasteride to increase awareness among patients and prescribers.

This issue also reminds clinicians to be alert to the risk of neuropsychiatric reactions in all patients, including children and adolescents, who are prescribed montelukast. Warnings in the Patient Information Leaflet have been strengthened and highlighted for greater emphasis. It is recommended that patients and their caregivers are directed to read the list of neuropsychiatric reactions in the Patient Information Leaflet and to seek medical advice immediately should they occur. Treatment should be discontinued with the occurrence of new or worsening neuropsychiatric symptoms.

This issue also contains a summary of letters to healthcare professionals in March. These generally related to supply issues and recalls.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.

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